Catheter/fistula needle to bloodline connection assurance device

ABSTRACT

In general, multiple embodiments of a catheter/fistula needle to bloodline connection assurance device, which secures and strengthens a connection between an extension tube end of a catheter or fistula needle and a bloodline, are provided. One embodiment includes internal and external clamshells. Internal clamshell halves pressure seal to the bloodline connector, and form outwardly extending barbs. The external clamshell opens rotatably about at least one hinge and includes inwardly facing threads that catch the outer barbs of the internal clamshell. After a user connects the catheter or fistula needle to the bloodline, the user closes the internal clamshell about the bloodline connector. Then, the user closes the external clamshell about the internal clamshell, causing the inwardly facing barbs of the external clamshell to engage the outwardly facing barbs of the internal clamshell. Such engagement prevents axial movement of the bloodline connector relative to the external clamshell.

PRIORITY CLAIM

This application is a divisional of U.S. application Ser. No.12/640,696, filed Dec. 17, 2009, which claims the benefit of U.S.Application Ser. No. 61/139,325, filed Dec. 19, 2008, the entirecontents of each of which are hereby incorporated by reference andrelied upon.

BACKGROUND

The present disclosure relates to securing and strengthening aconnection between an extension tube end of a catheter or fistula needle(device gaining access to a patient's vein) and a bloodline (running toa blood treatment machine).

Catheters and fistula needles used with a blood treatment machinetypically have two connectors, one for attachment to a venous bloodlineand the other for attachment to an arterial bloodline; the venous andarterial bloodlines attached then being to the blood treatment machine.While the catheter and fistula needle connecters can be provided in avariety of shapes and sizes, the connectors are typically female luerconnector. The distal end (with respect to the blood treatment machine)of each of the venous and arterial bloodlines includes a bloodlineconnector having a male luer, which connects to respective catheter orfistula needle connectors, or female luer connectors.

A disconnection or failure of the connection of such bloodlineconnectors and catheter or fistula needle connectors while a patient isconnected to a blood treatment machine for treatment can cause seriousblood loss. A need therefore exists for a device that prevents thebloodlines from coming free from the catheter or fistula needle duringtreatment, for example, if tension is applied inadvertently to thebloodline.

The most commonly used method to date for securing a catheter or fistulaneedle to a bloodline for treatment is tape. Tape is wrapped around theconnection and then secured to a patient's skin. However, many patientsare irritated by the tape and will remove it from their skin, or willnot even apply tape to the connection or their skin to begin with,placing them at risk of accidental disconnection. Accordingly, anotherneed exists for the device is that it eliminates the need for tape.

As mentioned above, catheter and fistula needle connecters, whiletypically being female luer connectors, are provided in a variety ofshapes and sizes by a variety of manufacturers. Thus, a further needalso exists for the device to be compatible with the variety of industrycatheter and fistula needle connectors.

SUMMARY

In general, multiple embodiments of a catheter fistula to bloodlineconnection assurance device (“assurance device”), which secures andstrengthens a connection between an extension tube end of a catheter orfistula needle and a bloodline are provided herein. The assurance devicesecures both catheter and fistula needle types of patient access. Forconvenience, the present disclosure may only refer to one of either acatheter or fistula needle. It should be appreciated however that insuch instances, the present disclosure refers to both a catheter andfistula needle unless specified otherwise.

A first primary embodiment of the assurance device is configured to becompatible with any industrial catheter/fistula needle female luerconnector and is specifically configured for use with a bloodlineconnector having locking clips that are biased slightly outwardly fromthe bloodline connector.

The first embodiment of the assurance device is generally cylindricaland includes clamshell halves that open rotatably about at least onehinge. The first embodiment of the assurance device includes a barbedportion (the barbed end of the assurance device being thebloodline-to-machine end) and a luer housing portion (the luer end ofthe assurance device being the patient access end). Each of the barbedand luer portions includes a closing clip positioned at the open outeror non-hinged side of the respective clamshell halves. Each closing clipincludes a male element and a female element, which lock together tohold the assurance device closed when closed about the mated bloodlineand patient access luer connectors. A user opens the Assurance Device bymanually disengaging the male elements from their respective femaleelements.

The catheter/fistula needle or patient access end of the firstembodiment of the assurance device defines an opening that accommodatesan extension tube of any suitable industrial catheter or fistula needle.The bloodline end of the assurance device is left open, such that in oneimplementation, there is no end wall or surface extending inwardly fromthe clamshell halves at the far bloodline end. The open end accommodatesthe bloodline connector locking clips.

Each of the assurance device embodiments is made of a suitable plastic,which does not need to be approved for contact with medical fluids. Amore rigid polymer, such as polycarbonate may be desirable.

The first embodiment of the assurance device makes use of the lockingclips on the bloodline connector. The interior wall of the barbedportion of the clamshell halves defines a plurality of barbs that areconfigured to engage with the distal or moveable ends of the lockingclips. Each locking clip is biased slightly outwardly to fit between tworespective barbs. The barbs are spaced as close together as possible toprevent any axial movement of the bloodline connector when the assurancedevice is engaged about the mated connectors.

The interior wall of the luer housing portion does not define barbs andinstead has a diameter that is large enough to house any suitableindustrial catheter/fistula needle female luer connector.

After a user connects the catheter or fistula needle to the bloodline,the user places the connected catheter connector and bloodline connectorinto the assurance device, which when closed, locks the barbs onto theslightly outwardly biased locking clips of the bloodline connector. Thelocking prevents axial movement of the bloodline connector relative tothe Assurance Device.

Accordingly, in the first embodiment, a connection assurance device forsecuring a connection of a mated patient-end connector and bloodlineconnector can includes a cylindrical housing defined by a first halfrotatably connected to a second half, the cylindrical housing having afirst portion, an inside wall of the first portion defining a pluralityof barbs configured to engage with a distal end of a clip which isbiased outwardly from the bloodline connector, to prevent axial movementof the bloodline connector relative to the connection assurance devicewhen the cylindrical housing is engaged about the mated patient-endconnector and bloodline connector, and a second portion, the secondportion configured to accommodate the patient-end connector; and atleast one closing mechanism for releasably securing the first half ofthe cylindrical housing to the second half of the cylindrical housing.

The patient-end connector can be a connector of an extension tube of adevice selected from the group consisting of: a catheter and a fistulaneedle. The at least one closing mechanism can include a clip having amale element and a female element. In an embodiment, when thecylindrical housing is engaged about the mated patient-end connector andbloodline connector, the distal end of the clip is engaged between twoof the plurality of barbs. The two clips can be biased outwardly fromthe bloodline connector and engage with the plurality of barbs. In anembodiment, the patient end connector includes a female luer receiverand the bloodline connector includes a male luer. Further, luer portioncan be configured to accommodate a plurality of shapes of patient-endconnectors when the cylindrical housing is engaged about the matedpatient-end connector and bloodline connector.

A second primary embodiment of the Assurance Device is also configuredto be compatible with any suitable industrial catheter/fistula needleconnector. The second embodiment includes internal and externalclamshells. Internal clamshell halves (could be hinged) pressure seal tothe bloodline connector, and form outwardly extending barbs.

The external clamshell opens rotatably about at least one hinge andincludes inwardly facing threads that catch the outer barbs of theinternal clamshell. The outer clamshell also defines a housing thataccommodates any industrial catheter/fistula connector. The externalclamshell includes a closing clip similar to the closing clip of thefirst embodiment of the assurance device.

The catheter/fistula needle end of the external clamshell defines anopening that accommodates an extension tube of any industrial catheteror fistula needle. The bloodline end of the external clamshell is leftopen, just as in the first embodiment of the assurance device toaccommodate a desired bloodline connector. It should be appreciatedhowever that the second embodiment does not require the bloodlineconnector to have the locking clips as does the first embodiment.

After a user connects the catheter or fistula needle to the bloodline,the user closes the internal clamshell about the bloodline connector.Then, the user closes the external clamshell about the internalclamshell, causing the inwardly facing barbs of the external clamshellto engage the outwardly facing barbs of the internal clamshell. Suchengagement prevents axial movement of the bloodline connector (engagedby the internal clamshell halves) relative to the external clamshell.

Accordingly, in the second primary embodiment, a connection assurancedevice for securing a connection of a mated patient-end connector andbloodline connector can comprise an external cylindrical housing definedby a first half rotatably connected to a second half, an inner wall ofthe external cylindrical housing including a plurality of inwardlyextending barbs; an internal cylindrical housing defined by a first halfand a second half each configured to engage about the bloodlineconnector, an outer wall of the internal cylindrical housing including aplurality of outwardly extending threads configured to engage with theplurality of inwardly extending barbs of the external cylindricalhousing when the external cylindrical housing is engaged about theinternal cylindrical housing; and at least one closing mechanism forreleasably securing the first half of the external cylindrical housingto the second half of the external cylindrical housing.

The patient-end connector can be a connector of an extension tube of adevice selected from the group consisting of: a catheter and a fistulaneedle. The at least one closing mechanism can include a clip having amale element and a female element. An inner wall of the internalcylindrical housing can define a cavity configured to engage anoutwardly extending portion of the bloodline connector. In anembodiment, the patient end connector includes a female luer receiverand the bloodline connector includes a male luer. The connectionassurance is again compatible with a plurality of shapes of patient-endconnectors. In an embodiment, the first half of the internal cylindricalhousing is rotatably connected to the second half of the internalcylindrical housing.

A third primary embodiment of the assurance device is also configured tobe compatible with any suitable industrial catheter/fistula needleconnector. The third embodiment of the assurance device includes aclamshell having two halves that open rotatably about at least onehinge. The assurance device includes a male luer portion that pressureseals to the male luer portion of the bloodline connector. The bloodlinemale luer portion of the device extends to a female luer portion, whichis lined with a compressible material that conforms around anyindustrial catheter/fistula needle connector when the assurance deviceis closed about the mated connectors. The third embodiment of theassurance device includes closing clips similar to those in the firstand second embodiments.

The catheter end of the third embodiment of the assurance device definesan opening that accommodates any industrial catheter or fistula femaleluer connector. The bloodline end defines an opening that accommodatesthe bloodline connector, which as with the second embodiment may or maynot include locking clips.

After a user connects the catheter to the bloodline, the user positionsthe male luer portion of the third embodiment of the assurance deviceinto engagement with the male luer of the bloodline connector. Once theassurance device is closed, this prevents axial movement of thebloodline connector relative to the assurance device. The female luer isaccordingly positioned along the compressible material in the femaleluer portion of the third embodiment of the assurance device, causingthe compressible material to conform about the female luer when theassurance device is closed about the mated connectors, and preventingboth axial and rotational movement of the female luer connector relativeto the assurance device.

Accordingly, the third primary embodiment of the connection assurancedevice for securing a connection of a mated patient-end connector andbloodline connector can include a cylindrical housing defined by a firsthalf rotatably connected to a second half, the cylindrical housinghaving: a first portion defined by the cylindrical housing, the firstportion configured to engage the bloodline connector when thecylindrical housing is engaged about the mated patient-end connector andbloodline connector, and a second portion defined by the cylindricalhousing, the second portion including a compressible material extendinginward from an inner wall of the lower portion, the compressiblematerial configured to conform about the patient-end connector when thecylindrical housing is engaged about the mated patient-end connector andbloodline connector; and at least one closing mechanism for releasablysecuring the first half of the cylindrical housing to the second half ofthe cylindrical housing.

The patient-end connector can be a connector of an extension tube of adevice selected from the group consisting of: a catheter and a fistulaneedle. The at least one closing mechanism can include a clip having amale element and a female element. The compressible material can be asponge-like material, and memory foam or be configured to absorb afluid. An inner wall of the first portion can define a cavity configuredto engage an outwardly extending portion of the bloodline connector. Thesecond portion can be configured to accommodate a plurality of shapes ofpatient-end connectors when the cylindrical housing is engaged about themated patient-end connector and bloodline connector.

It is accordingly an advantage of the present discloser to secure amachine tube to a patient access tube to increase safety during anextracorporeal treatment, which may be performed at home.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of a distal end (with respect to a bloodtreatment machine) of a bloodline having a bloodline connector includinga male luer, and the extension tubes of a catheter or fistula needle,each of the extension tubes including a female luer connector.

FIG. 2 is a perspective view of a first embodiment of the assurancedevice.

FIG. 3 is an exploded perspective view of the first embodiment of theassurance device in relation to a mated bloodline connector and catheteror fistula needle connector.

FIG. 4 is a perspective view of the first embodiment of the assurancedevice in a closed position about a mated bloodline connector andcatheter or fistula needle connector.

FIG. 5 is an exploded perspective view of a second embodiment of theassurance device.

FIG. 6 is an exploded perspective view of the second embodiment of theassurance device in relation to a mated bloodline connector and catheteror fistula needle connector.

FIG. 7 is a perspective view of the second embodiment of the assurancedevice in a closed position about a mated bloodline connector andcatheter or fistula needle connector.

FIG. 8 is an exploded perspective view of a third embodiment of theassurance device.

FIG. 9 is an exploded perspective view of the third embodiment of theassurance device in relation to a mated bloodline connector and catheteror fistula needle connector.

FIG. 10 is a perspective view of the third embodiment of the assurancedevice in a closed position about a mated bloodline connector andcatheter or fistula needle connector.

DETAILED DESCRIPTION

Referring now to the drawings and in particular to FIG. 1, eachembodiment of the assurance device discussed herein secures andstrengthens a connection between an extension tube end of a catheter orfistula needle (device gaining access to a patient's vein) and abloodline (running to a blood treatment machine). FIG. 1 shows anexample of a catheter 2 having two connectors 4, one for attachment to avenous bloodline and the other for attachment to an arterial bloodline.While the connecters 4 may be provided in a variety of shapes and sizes,each of connectors 4 is a female luer connector in one preferredembodiment.

FIG. 1 also illustrates an example of a distal end (with respect toblood treatment machine) of a bloodline 6 and a bloodline connector 8,which connects to catheter connector 4, or female luer connector. Thebloodline connector 8 accordingly includes a male luer 10 housed in aninternally threaded cavity that engages with the female luer receiver 12of the catheter connector 4. The bloodline connector 8 in FIG. 1includes two spring-like locking clips 14 that extend externally fromthe bloodline connector 8. The locking clips 14 attach the distal end ofthe bloodline 6 to the machine (not shown) in certain instances, such asfor priming and rinseback.

Referring now to FIGS. 2 to 4, a first primary embodiment of theassurance device is illustrated by device 20, which is compatible withany industrial suitable catheter/fistula needle female luer connectorand is specifically configured for use with the bloodline connector 8having spring-like locking clips 14 shown in FIG. 1, or a similarbloodline connector.

Referring to FIGS. 2 to 4, assurance device 20 is at least substantiallycylindrical and includes clamshell halves 22 a and 22 b that openrotatably about hinges 24 a and 24 b. It should be appreciated that invarious embodiments, the assurance device 20 may include a single hingeor multiple hinges. Halves 22 a and 22 b of the assurance device 20 mayalternatively be free from each other.

Assurance device 20 includes a barbed portion 26 and a luer housingportion 28. Each of barbed portion 26 and luer portion 28 includes aclosing clip 30 (FIG. 4) positioned at the open outer or non-hinged sideof the clamshell halves 22 a and 22 b. Each closing clip 30 includes amale element 32 a and a female element 32 b, which lock together to holdthe assurance device 20 closed when the device is closed about the matedluer connectors 4 and 8. A user opens the assurance device 20 bymanually disengaging the male elements 32 a from their respective femaleelements 32 b.

It should be appreciated that in various embodiments, the assurancedevice 20 may include a single closing clip 30 or other desirable numberof closing clips. Closing clip alternatively or additionally includessnap-fitting elements assurance devices could be held together using aloop and pile (Velcro) tape releasable fastener.

The catheter end of the assurance device 20 defines an opening formedfrom opening portions 34 a and 34 b defined by respective the clamshellhalves 22 a and 22 b. The opening 34 a/34 b accommodates any industrialsuitable catheter or fistula needle extension tube, such as those ofcatheter 2 in FIG. 1. The bloodline end of the Assurance Device 20 isleft open to accommodate the bloodline connector 8, as seen in FIG. 4.

As seen best in FIGS. 3 and 4, the first embodiment of the assurancedevice 20 makes use of the spring-like locking clips 14 of bloodlineconnector 8. The interior wall of the barbed portion of the clamshellhalves 22 a and 22 b defines a plurality of barbs 36 that are configuredto engage with the distal or moveable ends 16 of the locking clips 14.Each spring-like locking clip 14 is biased slightly outwardly to causethe distal or moveable ends 16 to fit between two respective barbs 36.The barbs 36 are spaced as close together as possible to prevent anyaxial movement of the bloodline connector 8 when the assurance device 20is engaged about the mated connectors 4 and 8.

The interior wall 38 of the luer housing portion 28 does not definebarbs and has a diameter that is large enough to house any suitableindustrial catheter/fistula needle connector, such as connector 4illustrated in FIG. 1.

As seen in FIGS. 3 and 4, after a user connects the catheter or fistulaneedle 2 to the bloodline 6, the user places the connected catheterconnector 4 and bloodline connector 8 into the assurance device 20,which when closed, locks barbs 36 onto the moveable ends 16 of theslightly outwardly biased locking clips 14 of the bloodline connector 8.

Referring now to FIGS. 5 to 7, a second primary embodiment of theassurance device is illustrated by assurance device 120, which isconfigured to be compatible with any suitable industrialcatheter/fistula needle connector and is specifically configured for usewith the bloodline connector 8 or a similar bloodline connector.

Assurance device 120 includes internal and external clamshells. Internalclamshell halves 123 a and 123 b pressure seal to bloodline connector 8and form outwardly extending barbs 137. In an alternative embodiment,internal clamshell halves 123 a and 123 b are hinged together andhingedly close about bloodline connector 8.

External clamshell halves 122 a and 122 b rotatably open about hinge 124and include inwardly facing threads 136 that catch or lock onto outerbarbs 137 of the inner clamshell halves 123 a and 123 b. The outerclamshell halves 122 a and 122 b also define a housing that accommodatesany suitable industrial catheter/fistula connector.

Assurance device 120 includes a closing clip 130 (FIG. 7) positioned atthe open outer or non-hinged side of the external clamshell halves 122 aand 122 b. Closing clip 130 includes a male element 132 a and a femaleelement 132 b, which lock together to hold the assurance device 120closed when closed about the mated luer connectors 4 and 8. A user opensthe assurance device 120 by manually disengaging the male element 132 afrom the respective female element 132 b. Any alternatives discussedabove for locking clip 30 is also applicable to closing clip 130.

The catheter end of the external clamshell defines an opening formed ofopening portions 134 a and 134 b defined by respective clamshell halves122 a and 122 b. Opening 134 a/134 b accommodates tube extending off ofany suitable industrial catheter or fistula needle, such as those ofcatheter 2 in FIG. 1. The bloodline end of the external clamshell isleft open to accommodate the bloodline connector 8, as seen in FIGS. 6and 7.

Referring to FIGS. 6 and 7, after a user connects the catheter orfistula needle 2 to the bloodline 6, the user pressure fits the internalclamshell halves 123 a and 123 b about the bloodline connector 8. Then,the user closes the external clamshell halves 122 a and 122 b about theinternal clamshell halves 123 a and 123 b, causing the inwardly facingbarbs 136 of the external clamshell halves 122 a and 122 b to engage theoutwardly facing barbs 137 extending from the internal clamshell halves123 a and 123 b.

Referring now to FIGS. 8 to 10, a third primary embodiment of theassurance device is illustrated by assurance device 220, which iscompatible with any suitable industrial catheter/fistula needleconnector and is specifically configured for use with the bloodlineconnector 8 or a similar bloodline connector. It should be noted thatblood line connectors 8 may, but do not have to, include spring-lineclips 14 discussed above for either assurance device 120 or 220.

As best illustrated in FIG. 8, assurance device 220 includes a clamshellhaving two halves 222 a and 222 b that open rotatably about hinge 224.It should be appreciated that although FIGS. 8 and 9 illustrate theclamshell halves 222 a and 222 b having one hinge 224, the clamshellhalves 222 a and 222 b may be attached by a single hinge or otherdesired number of hinges or may be separate pieces.

Assurance device 220 includes a male luer portion 240 that pressureseals to bloodline connector 8. Male luer portion 240 extends to afemale luer housing portion 242, which is lined with a compressiblematerial 244 that conforms around any suitable industrialcatheter/fistula needle connector when the assurance device 220 isclosed about the mated connectors. Material 244 is in one embodiment arubber, sponge rubber, or memory foam having a relatively highcoefficient of friction. Silicone or neoprene may be suitable materials.Material 244 is adhered to female luer portion 242 in one embodiment.Material 244, e.g., if sponge-like, also provides the added benefit ofabsorbing fluid or blood in the event of luer disconnection. Frictionalmaterial 244 also prevents rotation of the catheter/fistula needlefemale luer connector 4 within device 220 and relative to the bloodlineconnector 8.

Each of the male luer portion 240 and female luer portion 242 includes aclosing clip 230 positioned at the open outer or non-hinged side of theclamshell halves 222 a and 222 b. Each closing clip 230 includes a maleelement 232 a and a female element 232 b, which lock together to holdthe assurance device 220 closed when closed about the mated luerconnectors 4 and 8. A user opens the assurance device 220 by manuallydisengaging the male elements 232 a from their respective femaleelements 232 b. Closing clip 230 includes any of the alternativeembodiments discussed above for clip 30.

The catheter end of the clamshell defines an opening formed from openingportions 234 a and 234 b located on respective clamshell halves 222 aand 222 b. Opening 234 a/234 b accommodates a tube exiting from anysuitable industrial catheter or fistula needle, such as those ofcatheter 2 in FIG. 1. The bloodline end of the assurance device 220defines an opening formed from opening portions 235 a and 235 b locatedon respective clamshell halves 222 a and 222 b. Opening 235 a/235 baccommodates bloodline connector 8.

As seen in FIGS. 9 and 10, after a user connects the catheter to thebloodline, the user positions the upper portion of the assurance device220 in engagement with the bloodline connector 8. The female luerconnector 4 is accordingly positioned along the compressible material inthe female luer portion 238 of the assurance device 220, which causescompressible material 244 to squeeze to and conform about the femaleluer connector 4 when the assurance device 220 is closed about the matedconnectors 4 and 8. Again, device 200 is advantageous in one respectbecause it confines female luer connector 4 movement both axially androtationally.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A connection assurance devicefor securing a connection of a patient-end connector to a bloodlineconnector, the connection assurance device comprising: an externalcylindrical housing including a first portion mated to a second portion,an inner wall of the external cylindrical housing including a pluralityof inwardly extending projections; an internal cylindrical housingincluding a first portion and a second portion each configured to engagethe bloodline connector, an outer wall of the internal cylindricalhousing including a plurality of outwardly extending projectionsconfigured to engage with the plurality of inwardly extendingprojections of the external cylindrical housing when the externalcylindrical housing is placed about the internal cylindrical housing;and at least one closing mechanism for releasably securing the firstportion of the external cylindrical housing to the second portion of theexternal cylindrical housing.
 2. The connection assurance device ofclaim 1, wherein at least one of (i) the inwardly extending projectionsare inwardly extending barbs or (ii) the outwardly extending projectionsare outwardly extending threads.
 3. The connection assurance device ofclaim 1, wherein the at least one closing mechanism includes a clipprovided by the external housing having interlocking male and femaleelements.
 4. The connection assurance device of claim 1, wherein aninner wall of the internal cylindrical housing defines a cavityconfigured to engage an outwardly extending feature of the bloodlineconnector.
 5. The connection assurance device of claim 1, wherein thefirst portion of the external cylindrical housing is hingedly connectedto the second portion of the external cylindrical housing.
 6. Theconnection assurance device of claim 1, which is configured to becompatible with a plurality of shapes of patient-end connectors.
 7. Theconnection assurance device of claim 1, wherein the first portion of theinternal cylindrical housing is hingedly connected to the second portionof the internal cylindrical housing.
 8. A connection assurance devicefor securing a connection of a patient-end connector to a bloodlineconnector, the connection assurance device comprising: an externalhousing including a first portion mated hingedly to a second portion, aninner wall of the external housing including a plurality of inwardlyextending projections; an internal housing including a first portion anda second portion each configured to engage the bloodline connector, anouter wall of the internal housing including a plurality of outwardlyextending projections configured to engage the plurality of inwardlyextending projections of the external housing when the external housingis placed about the internal housing; and at least one closing mechanismfor securing the first portion of the external housing to the secondportion of the external housing.
 9. The connection assurance device ofclaim 8, wherein at least one of the external or the internal housing isa cylindrical housing.
 10. The connection assurance device of claim 8,wherein the at least one closing mechanism includes a clip provided bythe external housing, the clip having a male element and a femaleelement.
 11. The connection assurance device of claim 8, wherein atleast one of (i) the inwardly extending projections are barbs or (ii)the outwardly extending projections are threads.
 12. The connectionassurance device of claim 8, which is configured to be compatible with aplurality of shapes of patient-end connectors.
 13. The connectionassurance device of claim 8, wherein the first portion of the internalhousing is connected rotatably to the second portion of the internalhousing.
 14. A method for securing a connection of a mated patient-endconnector to a bloodline connector, the method comprising: closing aninternal housing about the bloodline connector, an outer wall of theinternal housing including a plurality of outwardly extendingprojections; closing an external housing about the internal housing,such that a plurality of inwardly extending projections of the externalhousing releasably engage the outwardly extending projections of theinternal housing; and securing the external housing about the internalhousing.
 15. The method of claim 14, wherein at least one of theinternal or external housings is cylindrical.
 16. The method of claim14, wherein securing the external housing includes clipping externalhousing components together.
 17. The method of claim 14, which includesengaging an outwardly extending portion of the bloodline connector withthe internal housing.
 18. The method of claim 14, which includeshingedly closing the internal housing about the bloodline connector. 19.The method of claim 14, which includes hingedly closing the externalhousing about the internal housing.
 20. The method of claim 14, whereinengaging the projections includes engaging barbs to threads.